Kornimate/medical-research-clean huggingface dataset:
study to gather information about the proper dosing and safety of the oral fxia inhibitor bay 2433334 in patients following an acute heart attack

Conditions: Acute Myocardial Infarction

Summary: the purpose of this study is to try to find the best dose of the new drug bay 2433334 to give to participants and to look at how well bay 2433334 works on top of a dual antiplatelet therapy (acetylsalicylic acid +/- clopidogrel) in patients following a recent heart attack (myocardial infarction) that happens when a blood vessel in the heart suddenly becomes blocked. bay 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral fxia inhibitor.


Eligibility criteria:
inclusion criteria: * participants must be 45 years of age or older, at the time of signing the informed consent * acute myocardial infarction (excluding mi associated with pci or cabg revascularization procedures) with: * clinical symptoms of acute myocardial infarction and * elevated biomarkers of myocardial necrosis (creatine kinase-muscle and brain isoenzyme \[ck-mb\] or cardiac troponins) and * at least one of the following risk factors need to be fulfilled: * age ≥ 65 years * prior mi (before the index ami event) * prior peripheral arterial disease * diabetes mellitus * prior coronary artery bypass grafting (cabg) and * initial angiography and revascularization procedures, either pci or cabg, as treatment for the index event performed before randomization. (note: a planned, staged pci procedure can be performed after randomization) * plan for dual antiplatelet therapy (asa + p2y12 inhibitor) after hospital discharge for the index ami * randomization during hospitalization for the index ami event and latest within 5 days of hospital admission * capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. written informed consent has to be signed before any study-specific procedure. exclusion criteria: * hemodynamically significant ventricular arrhythmias or cardiogenic shock at time of randomization * active bleeding; known bleeding disorder, history of major bleeding (intracranial, retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding within last 6 months of randomization * planned use or requirement of full dose and long term anticoagulation therapy during study conduct.
efficacy and safety of fingolimod in patients with relapsing-remitting multiple sclerosis with optional extension phase

Conditions: Multiple Sclerosis

Summary: this study assessed the safety, tolerability, and efficacy of 2 doses of oral fingolimod versus interferon β-1a to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis.


Eligibility criteria:
inclusion criteria: * male and female patients between ages 18-55 with a diagnosis of multiple sclerosis (ms) * patients with a relapsing-remitting disease course * patients with expanded disability status scale (edss) score of 0-5.5 exclusion criteria: * patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc * pregnant or nursing women * patients who cannot tolerate treatment with an interferon other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: fty720 interferon rrms multiple sclerosis efficacy
hyperemic myocardial perfusion by adenosine at different doses

Conditions: Chronic Coronary Syndrome; Coronary Artery Disease; Ischemic Heart Disease

Summary: adenosine is a commonly used pharmaceutical stressor at cardiac magnetic resonance examinations to assess suspected chronic coronary syndrome (ccs). however, several studies have reported that the current use of adenosine does not induce adequate hyperemic response in a substantial number of patients, leading to false diagnostics. the aim of this trial is to investigate the hyperemic effect of the standard dose of adenosine (140 microgram/kg/min) to the high dose of adenosine (210 microgram/kg/min) to improve the diagnostic methods using adenosine as a stressor and ultimately improve treatment decisions and patient prognosis in ccs.


Eligibility criteria:
inclusion criteria: patients: 1. the subject has given their written consent to participate in the trial. 2. are referred to department of clinical physiology, skåne university hospital, for suspected or known ccs or heart failure 3. matches the inclusion criteria for sex and age (6 females and 6 males from each group in each age decade from 40 to \>80 years old) 4. matches the inclusion criteria for no known heart failure (group b) or known heart failure (group c) 5. no caffein intake \<24h prior to the examination healthy volunteers: 1. the subject has given their written consent to participate in the trial. 2. matches the inclusion criteria for sex and age (6 females and 6 males from each group in each age decade from 40 to \>80 years old) 3. no caffein intake \<24h prior to the examination exclusion criteria: patients: 1. acute referral (in-house patients) 2. clinically unstable 3. acute chest pain 4. severe or decompensated heart failure 5. non sinus rhythm (e.g. atrial fibrillation) 6. asthma or severe chronic obstructive pulmonary disease 7. known chronic renal failure (egfr \<45ml/min/1.73m2) 8. av-block ii or iii 9. left bundle branch block 10. systolic blood pressure \ 230 mmhg at rest 11. increased intracranial pressure 12. known allergy or adverse reaction to adenosine or mannitol 13. known allergy or adverse reaction to gadolinium contrast agents 14. treatment with medication containing dipyradimol or teofyllamin/teofyllin 15. claustrophobia 16. devices contraindicated to cmr imaging (pacemaker, implants, intracranial clips etc) 17. pregnancy or breast feeding (screened by question only) 18. inability to give informed consent due to mental state, language difficulties etc healthy volunteers: 1. any of the exclusion criteria for patients 2. blood pressure \> 140/90 measured according to clinical routine 3. known systemic disease 4. known cardiac disease 5. cardiovascular medication 6. medication that might influence cardiovascular health 7. smoking

Keywords: myocardial perfusion cardiac magnetic resonance adenosine
randomized study of caspofungin prophylaxis followed by pre-emptive therapy for invasive candidiasis in the intensive care unit (icu)

Conditions: Invasive Candidiasis

Summary: adults admitted to intensive care units are at risk for a variety of complications. infections due to the fungus called candida are of particular concern. the study will test the possibility that caspofungin, a new therapy for fungal infections, can successfully reduce the rate of candida infections in subjects at risk. it will also test if caspofungin is useful in treating subjects for this disease when diagnosed using a new blood test that is performed twice weekly, permitting earlier diagnosis than current practice standards.


Eligibility criteria:
inclusion criteria: * non-pregnant \>18 yrs of age * subjects admitted to icu during the preceding 3 days and expected to stay in the icu for at least another 48 hours.subjects can be enrolled on days 3-5 of icu admission. * subjects meeting the clinical prediction rule exclusion criteria: * subjects with an allergy/intolerance to caspofungin or echinocandin analog * absolute neutrophil count \<500/mm3 at study entry or likely to develop such a count during therapy * acquired immunodeficiency syndrome, aplastic anemia or chronic granulomatous disease * moderate or severe hepatic insufficiency * subjects who are pregnant or lactating * unlikely to survive \< 24 hours * subjects who have received systemic antifungal therapy within 10 days prior to study entry * documented active proven or probable invasive fungal infection upon enrollment * previously enrolled in this study * currently on another investigational agent or have received an investigational agent within 10 days prior to study entry.

Keywords: candida prophylaxis high risk adults intensive care unit (icu)
maps group therapy model for bipolar disorder

Conditions: Bipolar Disorder; Suicide

Summary: this study aims to develop the maps(m,monitoring;a,assessing;p,preventing or reducing relapse;s,smart goal setting) group therapy model for bipolar disorder patients as other adjuvant clinical treatment and develop the instruments for evaluating the severity of bipolar symptoms. the investigators insist to provide the psychosocial intervention for bipolar patients in the general hospital and offer appropriative adjuvant intervention except current psychiatric biological treatment. this study is a one-year project. first, the investigators like to translate the depression, anxiety and stress scale (dass) and the altman self-rating scale for mania (asrm) to chinese and finish the reliability and validity study. second, the investigators would like to develop the maps group therapy to enhance bipolar patients' insight, increased life quality and decrease suicidal ideation. this study is a case control study. all cases recruit from the psychiatric outpatient department of one medical center. the inclusion criteria are diagnosed as bipolar disorder, age from 18 to 65 and agree to sign the inform consent. the excluded criteria are hard to communicate, with acute psychiatric feature and severe physical illness. the investigators plan to hold the maps group three times and predetermine to recruit totally 30 patients as the case group. as to the control group, the investigators also recruit from the psychiatric outpatient department and those who treat as usual by control their gender, age and the same diagnosis as bipolar disorder. the only one different factor between the case group and the control group was attending the maps group therapy or not. in maps group therapy, two facilitators work with ten clients with twelve weekly sessions and three monthly booster sessions. self-report rating scales (dass and asrm) are completed at the beginning of each session. the investigators use dass and asrm to evaluate the severity of bipolar symptoms; bss for suicidal ideation; sf-36 for life quality. the hypothesis is "patients attended to maps group therapy have better symptoms control, lower suicidal ideation, better life quality and less use emergency department or admissions than those who didn't attend the group therapy".


Eligibility criteria:
inclusion criteria: * bipolar disorder outpatients in remission, defined as young mania rating scale score \< 6, hamiltone depression rating scale-17 \< 8 * age 18 to 65 years old * speaking mandarin * agree to sign the inform consent exclusion criteria: * those who were hard to communicate such as mental retardation, hearing impairment and etc * with acute psychotic feature * with severe physical illness

Keywords: bipolar disorder psychosocial intervention group therapy relapse prevention parasuicide recurrence hospitalization medication adherence self-injurious behavior quality of life
a study to assess the efficacy, safety, and tolerability of kpl-716 in reducing pruritus in chronic pruritic diseases

Conditions: Chronic Idiopathic Urticaria; Chronic Idiopathic Pruritus; Lichen Planus; Lichen Simplex Chronicus; Plaque Psoriasis

Summary: participants with diseases characterized by chronic pruritus experiencing moderate to severe pruritus will be enrolled in this pilot phase 2 study. the diseases characterized by chronic pruritus investigated in this pilot study currently include chronic idiopathic urticaria (ciu), chronic idiopathic pruritus (cip), lichen planus (lp), lichen simplex chronicus (lsc) and plaque psoriasis (pps).


Eligibility criteria:
inclusion criteria: 1. male or female aged 18 to 75 years 2. have clinical diagnosis of chronic idiopathic urticaria (ciu), chronic idiopathic pruritus (cip), lichen planus (lp), lichen simplex chronicus (lsc) and plaque psoriasis (pps) for at least 6 months 3. moderate to severe pruritus 4. female participants of childbearing potential must have a negative pregnancy test, be nonlactating, and have agreed to use a highly effective method of contraception, as specified in the protocol, from the screening visit until 10 weeks after final study drug administration 5. able to comprehend and willing to sign an informed consent form and able to abide by the study restrictions and comply with all study procedures for the duration of the study exclusion criteria: 1. use of prohibited medications within the indicated timeframe from day 1 to the end of study 2. is currently using medication known to cause pruritus 3. has any inflammatory, pruritic, and/or fibrotic skin condition other than the diagnosis that defines inclusion 4. laboratory abnormalities that fall outside the windows specified in the protocol at the screening visit 5. has an active infection, including skin infection 6. any medical or psychiatric condition which, in the opinion of the investigator or the sponsor, may place the participant at increased risk as a result of study participation, interfere with study participation or study assessments, affect compliance with study requirements, or complicate interpretation of study results

Keywords: pruritus, chronic pruritus, moderate to severe
non-interventional study on safety of liraglutide in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia. the aim of this trial is to investigate the safety profile of liraglutide under normal conditions of use.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes mellitus, including newly-diagnosed subjects or those already receiving other anti-diabetic medications including glp-1 analogues other than liraglutide, who require treatment with liraglutide according to the clinical judgment of their treating physician * subjects who are capable of giving study-specific signed informed consent before any collection of information exclusion criteria: * subjects with type 1 diabetes * subjects who are or have previously been on liraglutide * subjects who are participating in another clinical trial * subjects with a hypersensitivity to liraglutide or to any of the excipients (disodium phosphate dihydrate, propylene glycol, phenol, water for injections) * subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the following 6 months
muse-s headband system for improving anxiety and insomnia among breast cancer survivors

Conditions: Breast Carcinoma

Summary: this early phase i trial evaluates the feasibility and impact of a meditation headband system (muse-s) for breast cancer survivors. anxiety and insomnia are among the most common distresses in breast cancer survivors during and after chemotherapy, in part due to the side effects of chemotherapy, fear of cancer coming back, progression of the cancer, and uncertainty of the future. these distresses impair patients' well-being and quality of life (qol) in general, and their cancer treatment adherence and effectiveness in particular. meditation has been demonstrated to be an effective management tool of stress and anxiety and is given the highest level of evidence (grade a) in the systematic review-based guidelines by the society of integrative medicine. the portable, interactive, electroencephalographic (eeg) muse headband guided meditation has been shown to improve fatigue, qol, and stress in newly diagnosed breast cancer patients. the muse-s headband system may decrease anxiety and insomnia among breast cancer survivors.

primary objectives: i. to evaluate the frequency of use of meditation (a stress management technique) among breast cancer survivors. ii. to evaluate the feasibility of a wearable eeg headband, muse s, together with smartphone or tablet application (app) to guide breast cancer survivors' interactive meditation and sleep support. iii. to measure the impact of interactive meditation and sleep support through muse s among breast cancer survivors during or after chemotherapy on improving symptoms of anxiety and insomnia. outline: patients wear the muse s headband to bed every night for 8 weeks and meditate using the muse phone app during day hours for at least 5 minutes over 8 weeks.

Eligibility criteria:
inclusion criteria: * age between 18-80 * breast cancer first diagnosed with stage 1-4 breast cancer in the past 10 years * patients report experiencing anxiety and insomnia both rated \> 3 on a 0-10 scale (with 0 indicating none) at the time of enrollment * patients on anti-anxiety/anti-depressant medication must be on stable dose for 1 month prior to study enrollment and must stay on that same dose throughout the trial * has smart phone or tablet * patient willing to use google-based anonymous email account to sign up for muse * be willing to provide informed consent and complete all aspects of the study * have no contraindicating comorbid health condition which would interfere with the proper use of the muse-s (trademark) system, as determined by the clinical investigators exclusion criteria: * pregnant or breastfeeding individuals * individuals who have used a regular mindfulness practice or received integrative medicine therapy, including acupuncture/acupressure, mindfulness or stress-reduction programs, massage, and/or energy therapies within the past 60 days * currently taking medication for insomnia * an exclusionary unstable medical or mental health condition as determined by the patient's oncologist
the changes of body fat distribution in obese patients with pcos after lsg

Conditions: Polycystic Ovary Syndrome

Summary: polycystic ovary syndrome (pcos) is a common endocrine disorder, with a prevalence of 5% to 15% in premenopausal women. patients with pcos presents as abnormal menstruation, ovulation disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other metabolic abnormalities. abdominal fat accumulation, overweightness and obesity are frequently present in patients with pcos . visceral adipose tissue (vat) plays an important role in the pathogenesis of pcos.therefore，this study aim to investigate the changes of body fat distribution in obese women with pcos after laparoscopic sleeve gastrectomy (lsg), and to explore the factors that may predict the changes in body fat distribution in pcos patients after lsg.

this study consecutively enrolled 153 patients with obesity aged 18-45 years (83 with pcos and 70 control patients) who underwent lsg from may 2013 to september 2020 at the department of endocrinology, shanghai tenth people's hospital, with a 12-month follow-up. dual-energy x-ray absorptiometry (dexa) was used to assess body fat distribution.

Eligibility criteria:
inclusion criteria: 1. fmale aged 18- 45; 2. meet rotterdam criteria(2003); 3. body mass index (bmi)≥30 kg/m2 exclusion criteria: 1. gender is male; 2. younger than 18 years old or older than 45 years old ; 3. secondary obesity due to endocrine disorders; 4. history of malignant tumors; 5）sever hepatic and renal disease; 6) concurrent participation in other clinical trials; 7) sever endocrine and hereditary diseases; 8) mental illnesses that rendered them unable to provide informed consent; 9) patients declining to undergo complete study testing.

Keywords: laparoscopic sleeve gastrectomy body fat distribution dual-energy x-ray absorptiometry visceral adipose tissue
ubiquinol treatment in patients with heart failure and preserved ejection fraction

Conditions: Heart Failure

Summary: there are no studies specifically examining the effects of coenzyme q (coq) treatment on echocardiographic indices of diastolic function in elderly patients with heart failure with preserved ejection fraction (hfpef). in previous studies the only echocardiographic parameters studied were ejection fraction (ef) and chamber size. the objective of the proposed current study is to examine the effect of 16 weeks of ubiquinol therapy on diastolic function assessed by echocardiography in patients over the age of 50 with a clinical diagnosis of hfpef. ubiquinol (kaneka pharma), the reduced form of coq will be utilized for this study as it has been shown to have superior bioavailability when compared to oxidized coq.


Eligibility criteria:
inclusion criteria: * typical signs and symptoms of congestive heart failure (chf) (new york association class 2-4). * normal ejection fraction on echocardiography (ef ≥50%). * evidence of diastolic dysfunction on non-invasive imaging (e:e' \> 15 or e:e' \> 8 with other measures of diastolic dysfunction such as e/a \ 40 cc/m2 or presence of elevated left ventricular mass index or elevated pulmonary pressures). * stable medical therapy for 4 weeks prior to randomization exclusion criteria: * chronic atrial fibrillation. * acute coronary syndrome or coronary revascularization within 60 days. * clinically significant valvular disease. * known infiltrative cardiomyopathy (e.g. amyloidosis), hypertrophic cardiomyopathy or chronic pericardial disease. * inability/refusal to provide informed consent
bilevel noninvasive ventilation in infants with bronchiolitis presenting with apnea

Conditions: Bronchiolitis

Summary: this physiological study aims to compare bilevel positive airway pressure and continuons positive airway pressure in infants with severe bronchiolitis presenting with apnea

this study is a cross over randomized study which aims to compare the effect of 2 modes of noninvasive ventilation on the occurence of central apnea, as measured by electrical activity of the diaphragm

Eligibility criteria:
inclusion criteria: * children born at gestational age \> 36 weeks gestation * ventilated in non invasive ventilation (niv) for acute bronchiolitis (clinical criteria of the american academy of pediatrics) * having presented at least 1 apnea objectified by the parents or by a health care professional, as previously described (1), with one or more of the following characteristics: 1/associated with bradycardia \< 80 / min, 2/associated with desaturation \< 85% or 3/duration more than 10 seconds * informed consent signed by at least one of the two parents + oral agreement from the second parent before the intervention of the study (2nd signature to be collected as soon as possible) exclusion criteria: * with chronic respiratory insufficiency requiring home ventilation (niv or under long-term oxygen therapy, initiated at least 14 days before the start of the study) * ventilated in niv for more than 48 hours before inclusion * hemodynamically significant cardiac disease, primary ent or pulmonary pathology (malformative or genetic) or neuromuscular pathology * presenting a contraindication of a gastric tube (trauma or recent surgery concerning the cervical, pharyngeal or esophageal regions, severe coagulation disorders) * patient not affiliated to health care insurance
pharmacokinetics of tedizolid phosphate in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the proposed study is designed to characterize the pharmacokinetics of intravenous and oral tedizolid in patients with cystic fibrosis.

recent epidemiological studies have demonstrated that the presence of methicillin-resistant staphylococcus aureus (mrsa) in the airways of patients with cf is associated with more rapid lung function decline and a higher mortality. tedizolid is a new antibiotic with potent activity against mrsa. tedizolid is currently fda approved for treatment of skin soft tissue infections with mrsa. the proposed study is designed to characterize the pharmacokinetics of intravenous and oral tedizolid in patients with cf.

Eligibility criteria:
inclusion criteria: * diagnosis of cf based on positive sweat chloride or known cf mutation * age \> 17 years * able to spontaneously expectorate sputum exclusion criteria: * any clinically significant laboratory abnormalities * presence of an ongoing acute pulmonary exacerbation * pregnancy * serious past allergy to linezolid or tedizolid * no alcohol, nicotine, or caffeine-containing products during the study period